Improving mental health care for pregnant women with mood and anxiety disorders
Integration of Stepped Care for Perinatal Mood and Anxiety Disorders Among Women Attending MCH Clinics
This study is testing a new way to help pregnant women in Kenya who have mood and anxiety disorders by providing better screening and treatment through their regular health care visits.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 2970 (estimated) |
| Ages | 14 Years and up |
| Sex | Female |
| Sponsor | Kenyatta National Hospital Government |
| Locations | 2 sites (Nairobi and 1 other locations) |
| Trial ID | NCT06456307 on ClinicalTrials.gov |
What this trial studies
This trial evaluates a stepped-care intervention aimed at screening and treating perinatal mood and anxiety disorders (PMAD) among women attending maternal and child health clinics in Kenya. The intervention includes systematic screening for PMAD symptoms, the use of Problem Management Plus (PM+), and telepsychiatry services to enhance access to mental health care. By integrating mental health services into routine antenatal and postnatal care, the study seeks to improve detection and treatment rates of PMAD, which currently remain low due to inadequate provider training and resources. The trial will assess both clinical outcomes and the implementation of these integrated services in a resource-limited setting.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women who are at least 28 weeks gestation, attending antenatal care, and screening positive for PMAD symptoms.
Not a fit: Patients who are less than 28 weeks gestation or those at high risk of self-harm may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve mental health outcomes for pregnant women experiencing mood and anxiety disorders.
How similar studies have performed: Other studies have shown success in integrating mental health services into perinatal care, but this specific approach in Kenya is novel and untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pregnant and ≥28 weeks gestation * Attending ANC care at the facility * ≥14 years old * Screen positive for PMAD symptoms (PHQ-2≥3 and/or GAD-2≥3) * Willing to return to the MCH and PMTCT clinic for study visits Exclusion Criteria: * Less than 28 weeks gestation * Any woman at high risk of self-harm based on a study self-harm assessment protocol, * Has cognitive impairments or psychotic symptoms
Where this trial is running
Nairobi and 1 other locations
- Kenyatta National Hospital — Nairobi, Kenya (Recruiting)
- HomaBay, Siaya and Kisumu — Western Kenya, Kenya (Recruiting)
Study contacts
- Principal investigator: John Kinuthia, MBChB, MMed, MPH — Kenyatta National Hospital
- Study coordinator: Nancy Ngumbau, MBChB, MPH
- Email: nancym390@gmail.com
- Phone: +254713917226
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.